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HOPE-Duchenne (Halt cardiomyOPathy progrEssion in Duchenne)

NCT02485938 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-01-09

Study results available
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Summary

Male participants with cardiomyopathy secondary to Duchenne muscular dystrophy (DMD) meeting all inclusion and no exclusion criteria will be randomized. All participants will be at least 12 years of age. They will be randomized in a 1:1 manner to either intracoronary infusion of CAP-1002 in three coronary arteries supplying the three major cardiac territories of the left ventricle of the heart (anterior, lateral, inferior/posterior) or usual care. In the active treatment arm, all three major cardiac territories will be treated (infused) during a single procedure in an open-label fashion.

Conditions

Interventions

DRUG

Allogeneic Cardiosphere-Derived Cells (CAP-1002)

Intracoronary delivery of Allogeneic Cardiosphere-Derived Cells (CAP-1002)

Sponsors & Collaborators

  • Capricor Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Awadalla · Capricor Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-07
Primary Completion
2017-09-14
Completion
2017-09-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02485938 on ClinicalTrials.gov